– Support and comply with company Quality Policy and Quality Objectives, as well as other procedures, regulations, and standards

– Control and/or quarantine non-conforming materials

– Help develop and/or implement corrective/preventative actions

– Maintain control & traceability over products and work in-process

Other Duties & Responsibilities:

In addition to and/or inclusive of primary job function requirements, employee may be required to learn and/or assist with other duties and responsibilities. Such duties may include, but are not limited to:

– Participate in internal and external audits

– Work with, and for, other team members: Follow instructions and provide feedback in a professional and constructive manner

– Perform, or assist with, maintenance and calibration requirements

– Proactively maintain cleanliness of work area, cleanroom, and controlled areas without direction

– Debur and/or polish materials such as metals and/or plastics

– Work with others on production status including schedules, deadlines, part-process status, inventory control, and other production issues

– Must be able to wear protective equipment as directed up to 10 hrs/day, such as: Nitrile/vinyl gloves; surgical-style mask; isolation suit (Tyvek™ or similar) w/o makeup; hair net; shoe covers, as necessary

Support production related activities by assisting where necessary with planning & execution of manufacturing and assembly of medical devices. Work closely with employees, supervisors, and managers to accomplish required actions and results for production needs.

Primary

Responsibilities

to include, but not limited to:

– Comply with GMPs, regulations, standards, and other instructions at all times

– Assist in scheduling and monitoring production, as well as vendor and supplier activities using various software tools and methods such as Intuitive ERP, MS Excel, and others

– Work with, and for, other team members: Follow instructions and provide feedback in a professional and constructive manner

Position Summary: Hand finishing technician needed to perform hand finishing/polishing of precision metal components. This includes, but is not limited to: manually removing machining marks from metal components, utilizing the operator’s skills and knowledge to efficiently perform the manual blending, polishing and creation of edge-breaks on precision components with focus on quality and attention to detail. No specific experience is necessary, but candidates with polishing or other forms of metal finishing experience are preferred. Candidates from other industries such as jewelry manufacturing or dental technicians will also be considered.

Duties and Responsibilities:

Expertly perform sanding, polishing, sizing, and deburring functions using hand and power equipment such as bench and hand grinders, polishers, and belt sanders. May clean metal parts through the use of hand-wiping, solvent washing, and alkaline/caustic chemical cleaning. Check required dimensions using calipers, micrometers, height gauges and other inspection devices. Demonstrate proper and safe operation of equipment, and perform simple maintenance of same equipment. Work alongside other team members professionally and courteously. This is a 1st shift position reporting to the team supervisor.

Position Requirements:

Physical Requirements: Must be able to lift up to 40 pounds; Manual dexterity required for operating machinery and computers; Fine motor skills with frequent hand and arm movement. We are a Class III medical device manufacturer and are an Equal Opportunity Employer. We do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

Jarvik Heart, Inc. is a privately-held company that develops and manufactures miniaturized heart assist devices for the treatment of severe heart failure. The Jarvik 2000 Flowmaker, Jarvik Heart’s successful pilot heart pump, is an investigational device used in the United States to support patients awaiting heart transplants. In Europe, the Jarvik 2000 has earned CE mark certification for both bridge-to-transplant and lifetime use. As an investigational device, the Jarvik 2000 has been implanted in 800 heart failure patients with no mechanical failures, and has successfully sustained and improved the condition of patients awaiting transplants, as well as those who have chosen the device for lifetime use